3D Tissue Models
MAGI’s 2008 Clinical Trial Agreements, Budgets & Regulatory Conference – EAST
Hyatt Regency – Crystal City
2799 Jefferson Davis Highway
Arlington, VA

Schedule of Presentations:

Sunday, May 18, 2008
12:00:00 Early Registration
13:00:00 Concurrent Workshops - Choose One
17:00:00 Early Registration
19:00:00 Informal Get-Together in the hotel Lobbibar (no-host)
Monday, May 19, 2008
07:30:00 Registration, Networking & Light Breakfast
08:30:00 Chairman’s Opening Remarks Norman M. Goldfarb
09:00:00 FDA Amendments Act of 2007 Gregory M. Torre
10:00:00 Networking Break
10:30:00 Track B: Budgets Budget Development & Negotiation from A to Z John F. Covin, Terence L. Webb
10:30:00 Track A: Contracts Managing Risk: Indemnification, Subject Injury & Insurance Jeffrey Klein, Barbara Longmire, Lori Spencer
10:30:00 Track C: Special Topics Clinical Trial Registries David Heck
10:30:00 Track D: Regulatory Site Initiation for Sponsors Julia B. Isbell
10:30:00 Concurrent Tracks Begin - Choose from A-D
11:00:00 Track D: Regulatory Study Initiation for Sites Suzanne Coleman
11:00:00 Track C: Special Topics Clinical Trial Agreements in the United Kingdom Harriet Wibberley
12:00:00 Lunch with Speakers
13:15:00 Track C: Special Topics Profitable Clinical Research for Physician Offices & Clinics William B. Smith, Dave Jones
13:15:00 Track A: Contracts Publication & Intellectual Property Rights: Finding the Common Ground Stacie S. Switzer, Orman Simpson, LaDale George
13:15:00 Track D: Regulatory Working with IRBs Matt Baker, Sheila B. Noone
13:15:00 Track B: Budgets The Sponsor’s Role in Medicare Reimbursement for Device Trials Linda Johnson
13:45:00 Track B: Budgets Phase IV Study Budgets Gina Morton
14:15:00 Track B: Budgets Making, Tracking & Collecting Payments Geoffrey Schick
14:45:00 Networking Break
15:15:00 Track C: Special Topics The Three Rs: Reading, ’Riting & ’Rithmeticing Clinical Trial Agreements & Budgets Sylvia Lewis, Terry Stubbs
15:15:00 Track B: Budgets Inside the OIG’s Toolbox David Vulcano
15:15:00 Track D: Regulatory Adverse Events & Deviations
15:15:00 Track A: Contracts Negotiating Clinical Trial Agreements outside the U.S. John W. Herrmann
16:00:00 Track D: Regulatory Informed Consent Quincy J. Byrdsong, Caroline Rogers
16:00:00 Track A: Contracts Don’t Forget the Other Contract Terms Jane A. Wilcox, C. Elizabeth O'Keeffe
16:00:00 Track B: Budgets Medicare Reimbursement for Clinical Trials Barbara Veath, Douglass Reichgott
17:00:00 Track C: Special Topics Hospital/CRO Collaborative Partnerships Adam R. Chasse, Thomas F. Pianta
17:00:00 Track D: Regulatory From CRF to Database Pati Stone
17:00:00 Track A: Contracts Clinical Trial Agreements in Canada Karen Arts, John Akitt
17:00:00 Track B: Budgets Billing Compliance in Practice Patricia Bass, Debbie McAllister
17:45:00 Networking Reception
Tuesday, May 20, 2008
07:30:00 Registration, Networking & Light Breakfast
08:15:00 Chairman's Remarks
08:30:00 Face-Off: Subject Injury Mock Trial Wayne Bond
09:30:00 Negotiation Magic: Skills & Techniques Barry Sagotsky
10:15:00 Networking Break
10:45:00 Track C: Special Topics When Clinical Research Meets Tech Transfer Mark G. Bloom
10:45:00 Track B: Budgets Pricing Patterns & Trends Ying Jiang
10:45:00 Track A: Contracts Sensible Payment Terms Leann Frankel, John Akitt
10:45:00 Track D: Regulatory Delegation of Authority at Research Sites Belinda Vandersluis
10:45:00 Concurrent Tracks Begin - Choose from A-D
11:15:00 Track C: Special Topics Outsourcing Contract & Budget Negotiation to CROs Bill Hansen, Sharon Gordon
11:15:00 Track B: Budgets Investigator-Initiated Trial Budgets Jen Runne
11:15:00 Track D: Regulatory FDA Inspections of Research Sites Cheryl Dubenezic
11:45:00 Track B: Budgets NIH Grants & Proposals Rebbecca A. Moen, Matthew Staman
11:45:00 Track A: Contracts Clinical Trial Agreements for Investigator-Initiated Trials Frederick M Frankhauser
12:15:00 Track D: Regulatory Regulatory Challenges in International Subject Recruitment Diana L. Anderson
12:15:00 Track A: Contracts Clinical Trial CRADAs with the Department of Veterans Affairs Amy Centanni, Jeffrey Moore
12:15:00 Track C: Special Topics Identifying Problem Investigators
13:00:00 Lunch: Birds of a Feather
13:45:00 OPTIONAL: Clinical Research Contract Professional (CRCP) Certification Exam
14:15:00 Track D: Regulatory Conflicts of Interest Priya Sankar
14:15:00 Track A: Contracts Other Intellectual Property Agreements Alan Jakimo
14:15:00 Track C: Special Topics Understanding Your Insurance Policy Lyn Rossano
14:15:00 Track B: Budgets Budgeting for International Trials Lori Shields
14:45:00 Track B: Budgets Managing Currency Risks in International Trials
14:45:00 Track D: Regulatory Investigator-Initiated Trials Harvey M. Arbit
15:00:00 Track C: Special Topics Multimedia Informed Consent Susan Brink
15:45:00 Networking Break
16:15:00 Stump the Experts
17:00:00 Chairman's Closing Remarks
Wednesday, May 21, 2008
07:15:00 Registration, Networking & Light Breakfast
08:00:00 Workshop C: Budget Development & Negotiation for Large Investigative Sites Geoffrey Schick
08:00:00 Workshop E: Clinical Research Law & Litigation Fred Rom, Wayne Bond
08:00:00 Workshop B: The Big Four Terms: Indemnification, Subject Injury, Intellectual Property, and Publication Right Julia Jackson, Suzanne Page, Penny Smith
08:00:00 Concurrent Workshops - Choose One
08:00:00 Workshop A: Dissecting a Clinical Trial Agreement Mark E. Boulding, Anne Prather, J. Andrew Lemons
08:00:00 Workshop D: Practical Negotiation Barry Sagotsky
12:00:00 Networking Lunch
13:30:00 OPTIONAL: Clinical Research Contract Professional (CRCP) Certification Exam
14:45:00 Conference Concludes
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